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After Almost 4 Years, FDA Says Mesoblast Phase 3 Therapy Data Can Support Resubmission For Serious Complications in Children Following Stem Cell Transplant

Monday, the FDA informed Mesoblast Limited (NASDAQ:MESO) that following additional consideration, the available clinical data from its Phase 3 study MSB-GVHD001 appears sufficient to support submission of the proposed Biologics License Application (BLA) for remestemcel-L for pediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD). “We thank the agency for their collaborative approach. The responses and guidance from FDA are clear and provide us with a high level of ....

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Mesoblast Receives Complete Response From U.S. Food and Drug Administration for Biologics License Application for Steroid-Refractory Acute Graft Versus Host Disease in Children

Mesoblast Receives Complete Response From U.S. Food and Drug Administration for Biologics License Application for Steroid-Refractory Acute Graft Versus Host Disease in Children
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Mesoblast Limited (MESO) Receives CRL from FDA for Steroid-Refractory Acute Graft Versus Host Disease in Children

Mesoblast Limited (MESO) Receives CRL from FDA for Steroid-Refractory Acute Graft Versus Host Disease in Children
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Mesoblast Shares Tumble As FDA Strikes Out Cell Therapy Application For Children Again, Requires Additional Trial - Mesoblast (NASDAQ:MESO)

The FDA issued a complete response letter to Mesoblast Limited's (NASDAQ: MESO) resubmission for remestemcel-L for pediatric steroid-refractory acute graft  ....

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Mesoblast Limited Receives Complete Response from U.S. Food and Drug Administration for Biologics License Application for Steroid-Refractory Acute Graft Versus Host Disease in Children

Mesoblast Limited announced that the US Food and Drug Administration has provided a complete response to its Biologics License Application resubmission for remestemcel-L for the treatment of. ....

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